Thursday, March 17, 2022 5:04:30 PM
" SEMDEXA: The 10-K confirms the complete six-months data analysis is expected this month and SRNE to submit request to FDA for Breakthrough Therapy Designation that will expedite NDA approval. Remember a 10-K is a very conservative document, there’s pages and pages of every imaginable risk, e.g. sky is falling, use 2 condoms, etc. While SRNE says they expect to submit a pre-NDA meeting request to FDA in 1H22, I still see FDA approval happening in late Q4. The opioid crisis because of the enormous death toll is foremost a political crisis and FDA responds to politics. Once SEMDEXA’s results become widely known thanks to publication in JAMA, NEJM, and the (4) major pain conferences Scilex will sponsor in 2022, don’t be surprised some morning NBC Today Show, etc. are talking about SEMDEXA! That’s when we know SRNE has arrived. The tiny hairline crack in the Hoover Dam suddenly starts to get bigger as the soccer moms (hydrostatic pressure) light up congressmen’s offices, who in turn pound the FDA, who are back blowin’ big pharma again (structural failure) when the dam bursts!! SEMDEXA NDA approval is about as sure a thing as we’ll ever see. Know what you own !!"
"The refusal of the real is the number one dogma of our time" Rene Girard
Recent SRNE News
- Form 8-K - Current report • Edgar (US Regulatory) • 11/03/2023 09:31:06 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/27/2023 08:15:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/13/2023 01:51:06 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/28/2023 09:25:07 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 08/07/2023 08:15:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/01/2023 10:01:54 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/13/2023 10:26:26 AM
Last Shot Hydration Drink Announced as Official Sponsor of Red River Athletic Conference • EQLB • Jun 20, 2024 2:38 PM
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VAYK Assembling New Management Team for $64 Billion Domestic Market • VAYK • Jun 18, 2024 9:00 AM
Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
Hydromer Announces Attainment of ISO 13485 Certification • HYDI • Jun 17, 2024 9:22 AM